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Once thought to potentially have too many shortcomings, like a short half-life in vivo and stability issues, scientific progress has moved ribonucleic acid (RNA) technology to the forefront of research for new drugs and vaccines to treat an array of maladies. Researchers now understand how to leverage the strong safety profile of RNA as an easily metabolized transient carrier of genetic information instructing the body’s immune system to produce proteins to deal with pathogens or damaged cells.

Perhaps nothing exemplifies the value of potential RNA vaccines more than Eli Lilly (LLY) recently agreeing to pay up to $1.8 billion to work with the mRNA (messenger RNA) experts at CureVac AG on a portfolio of five mRNA cancer vaccines in development. It further shines a spotlight on companies like Halifax, Canada-based Immunovaccine (IMV:CA)(IMMVF) and the fact that investors and scientists alike are looking ahead to clinical data this quarter from Immunovaccine’s DepoVax cancer vaccine platform.

What companies like CureVac and Immunovaccine are doing is part of the broad category of immunotherapeutics that has taken the life sciences industry by storm in recent years and garnered billions of dollars in investment. Immunotherapeutics represent the potential for more precise cancer treatments than traditional oncology methods by harnessing the body’s own immune system. Much of the next stage of advancements revolve around improved drug delivery. According to Immunovaccine’s website, “how we deliver instructions to the human immune system is the key to generating a pivotal, sustained response against diseases previously unresponsive to immunotherapies.”

Wall Street is starting to take notice of the company's growing momentum as well. On Oct. 12, Echelon Wealth Partners analyst Douglas Loe ascribed Immunovaccine as a "Top Pick", as reported by The Globe and Mail The Globe and Mail. Loe rates Immunovaccine as a "speculative buy," with a bullish $2.75 target, as compared with the average analyst target of $2.36. Shares of Immunovaccine are currently trading around $1.33 on the Toronto Stock Exchange.

"IMV performs well year-to-date, in part from overall sector attractiveness, but substantively from its own [DepoVax] pipeline advances as well," Loe explained in his report. "Our shift to ImmunoVaccine as a 2017 'Top Pick' is driven in part by our underlying positive regard for its DepoVax platform. ... Year-to-date, IMV shares have generated strong returns of 66.2 per cent despite modest share price recalibration since May, 2017, and we believe returns have been generated through seminal pipeline advances on the firm's lipid-based, water-free antigen formulation platform DepoVax, for which multiple phase I/II clinical initiatives -- mostly in cancer and infectious disease -- are either ongoing or about to be."

DepoVax – Long and Strong Attacks on Tumors

With DepoVax, the innovation is in the delivery formulation to present extended stimulation to the immune system to fight disease by mitigation degradation of antigens or synthetic peptides. A true platform technology for cancer and infectious disease vaccine candidates, DepoVax utilizes a 100% oil-based, “no release” depot delivery system. This is achieved by taking novel antigen candidates, formulating them within liposomes (tiny bubbles comprised of cell material), freeze drying the formulation to remove all the water content to ensure stability and suspending a drug candidate before reconstitution in an oil formulation for delivery.

What results from the preceding steps is extended uptake and protracted exposure to the antigen or adjuvant combination to the immune system, eliciting a rapid, robust and sustained response to attack specific targets. The beauty of the platform is the versatility. It can be used to develop novel stand-alone therapies or it can be readily combined with other immunotherapeutic approaches, such as potent immune modulators and popular checkpoint inhibitors, for the purpose of improving clinical outcomes. Moreover, DepoVax technology has been proven safe in hundreds of human subjects, facilitating regimens that can range from single-dose to multiple injections without fear of serious adverse events.

Apropos, Immunovaccine in July had a major breakthrough in personalized cancer immunotherapies with its DPX-NEO program, a collaboration with UConn Health. For the first time, their scientists successfully formulated 14 neoepitope cancer peptides into one single DepoVax formulation. Neoepitopes independently are revered for their potential because they function as unique tumor-specific antigens that the adaptive immune system uses to selectively target tumors without collateral damage to healthy cells. In lab studies, Immunovaccine’s new combination cancer vaccine demonstrated the ability to generate specific killer T-cell responses against cancer peptides.

While still early, a vaccine of this scale and design could be groundbreaking.

“We believe that the ability to effectively combine a high number of diverse peptides without manufacturing limitations represents an important milestone in the deployment of personalized neoepitope immunotherapies,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “Being able to do it so quickly and efficiently should provide an opportunity to develop truly personalized therapies on a scale that could, in our opinion, truly impact the way in which bespoke medicines are used in today’s treatment landscape.”

Biotechs, Pharma, Peers and Regulators Recognizing the Power of the Platform

The novelty and safety of DepoVax has led to multiple clinical studies and collaborations with some of the biggest names in oncology, including the aforementioned UConn Health, Merck (MRK), Incyte Corp. (INCY) and Dana-Farber Cancer Institute. Regulatory agencies have awarded several designations for Immunovaccine’s lead cancer vaccine called DPX-Survivac, so named for the treatment targeting survivin, an important cancer stem cell antigen, cancer instigator and biomarker of cancer progression.

The U.S Food and Drug Administration has awarded Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation as a maintenance therapy for certain ovarian cancer patients. The European Medicines Agency as also awarded an Orphan Drug designation for ovarian cancer. These designations bring with them implications for expedited development and extended patent protection should products eventually be commercialized.

In the clinic, two of its T-cell activation therapies have successfully completed Phase 1 trials, while a Phase 1b trial in collaboration with Incyte is ongoing evaluating DPX-Survivac as a triple combination therapy with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat, and low dose oral cyclophosphamide in recurrent ovarian cancer patients.

A separate Phase 2, investigator-sponsored Phase 2 trial is near recruitment to assess the safety and anti-tumor activity of DPX-Survivac in combination with Merck’s anti-PD-1 antibody pembroluzimab and low-dose cyclophosphamide as a new ovarian cancer treatment.

Outside of the cancer spectrum, the company is exploring additional applications of DepoVax, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has recently successfully completed a Phase 1 clinical trial. Potentially fatal to infants and the elderly, there are no approved vaccines for RSV, a menacing bacteria that causes 64 million infections and 160,000 deaths annually, according to the World Health Organization. To lend some color to the prolonged exposure quality of the vaccine, researchers noted a highly immunogenic responses from DPX-RSV in the study, which endured up to one year from the initial dosing. Data on this trial will be presented at the 4th ReSViNET (Respiratory Syncytial Virus Network) Experts’ Meeting taking place in Malaga, Spain from November 29 to December 1, 2017.

Immunovaccine also has ongoing clinical projects to assess the potential of DepoVax™ to address malaria and the Zika virus, once a relatively modest problem that has turned into a global terror.

Showing the true utility of the platform, Immunovaccine also has a strong partner in global animal health company Zoetis (ZTS), namely for developing cattle vaccines. At the end of August, the company achieved several milestones in this collaboration, comprised of controlled studies hitting their primary immunity and duration endpoints against two disease targets. These successful trials pave the way for late-stage testing of the enhanced vaccines.

Speaking to the successful research, Frederic Ors, Immunovaccine’s Chief Executive Officer said, “We are extremely pleased with the recent progress of our long-standing collaboration with Zoetis, and the continuation of these vaccine candidates into later-stage testing. Our development platform continues to exceed our expectations, repeatedly demonstrating that its unique mechanism of action can translate into meaningful efficacy and clinical benefits across multiple indications.”

Multiple Shots

Clearly one of the things that attracted Merck to CureVac was a little clinical evidence and a stack of supporting preclinical work demonstrating the diversity of CureVac’s technology to address multiple cancer indications. Simply, there’s value in multiple opportunities, even at an early stage. Immunovaccine is cut from a similar cloth, with its proprietary platform technology already showing its reach and commanding the attention of some of the biggest names in respective fields, whether oncology or infectious disease (or animal or human for that matter). Immunovaccine has developed an eloquent method for slipping a lethal dose of medicine into the center of a disease and encoding cells to spark an immunological response not just for a single jolt, but for an extended period of time. Investors would be wise to see what is disclosed this quarter with respect to clinical research and to look for more lucrative partnering deals if the technology continues to prove itself alone or in a way to make drug combinations even more powerful.

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